A study to determine serum periostin levels over a six month period in adult patients, following a fracture

Not Applicable

Completed

• Conditions: Serum Periostin levels, following a fracture; Serum periostin levels, following planned knee or hip joint replacement; Serum periostin levels, following open reduction internal fixation (ORIF) surgery; Injuries and Accidents - Fractures; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12614000151639
• Lead Sponsor: Medical Research Institute of New Zealand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

Aged between 18 to 75 years
Able to provide informed consent
Experienced a fracture to short or long bone less than 48 hours prior, or undergoing hip or knee joint replacement, or or open reduction internal fixation (ORIF) surgery
Participants will be enrolled to the following groups:
34 participants with a short-bone or phalangeal fracture
34 participants with a long bone fracture
34 participants undergoing hip or knee joint replacement surgery, or open reduction internal fixation (ORIF) surgery

Exclusion Criteria

Doctor’s diagnosis of Asthma, Bronchitis or COPD
Wheezing or use of respiratory inhalers in the past 12 months
Known pregnancy
Significant co morbidities (determined at investigator discretion)
Hospital admission within last 3 months
Surgery within last 3 months, determined at investigator discretion (this includes all major surgery requiring general anaesthetic, dental extractions and root canal procedures. This does not include minor procedures, including but not limited to mole or wart removal, dental fillings etc).
Systemic Corticosteroids within the last 3 months
Any other safety concern at the investigator’s discretion

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum periostin levels over a six month period following a fracture[Serum periostin will be measured at: Baseline (within 48 hours post fracture or surgery), week 1, week 2, week 4 , week 8, week 12 and 6 months post baseline.<br>For patients undergoing planned knee or hip joint replacement, an additional pre-operative sample will be taken at up to 3 months prior to Baseline]

Secondary Outcome Measures

Name	Time	Method
Investigation of potential associations between serum periostin and non-asthmatic health conditions (as captured by general health questionnaire e.g. diabetes) <br>[Baseline visit (within 48 hours of fracture occuring)<br>For patients undergoing planned knee or hip joint replacement, the questionnaire will be administered at the pre-operative time point (up to 3 months prior to Baseline)]